Healthy Volunteers Clinical Trial
Official title:
Feasibility Study on Radiofrequency-Based Selective Electrothermolysis to Investigate Its Effects on Human Skin
Verified date | June 2023 |
Source | Johns Hopkins University |
Contact | Ruizhi Wang |
Phone | 410-502-7546 |
rwang[@]jhmi.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research is being done to assess the effect of radiofrequency (RF)-based treatment on skin and skin conditions.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | August 2026 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. For primary objective: healthy volunteers and HS patients between 22 and 70 years of age. 2. Participants must be healthy enough to undergo multiple skin biopsy in the opinion of the investigator. 3. Participants must provide informed consent. 4. Participants must have the ability and willingness to follow all study procedures, attend scheduled visits, and successfully complete the study. 5. Participants must have the ability to understand and communicate with the investigator. 6. For HS patients, participants will have localized disease to the axillae, mild to moderate severity and no evidence of active infection as assessed by the investigator Exclusion Criteria: 1. Participants unable to provide informed consent. 2. Recently treated for current skin diseases that would affect clinical evaluation. 3. Known contraindications to selective electrothermolysis treatment. 4. Immunocompromised patients 5. Participants on systemic steroids 6. Participants on immune modulators 7. Participants on blood thinners 8. Participants with bleeding disorders 9. Participants with any active infections or currently treated infections 10. Participants with significant medical history or concurrent illness that the investigator feels is not safe for biopsy or study participation. 11. Noncompliant participants. 12. Pregnant or nursing participants (qualitative human chorionic gonadotropin (hCG) testing will be performed prior to each treatment). 13. Participants with allergy to anesthetics. 14. Participants with a history of keloids or hypertrophic scars within the past 10 years. 15. Participants who have taken oral/topical antihistamines, oral/topical analgesics, and/or other medications that the investigators believe will impact the study. 16. Participants who are currently taking or who have taken in the past 12 months any medications that may impair wound healing, such as systemic retinoids. 17. Participants who cannot undergo motor strength and sensory testing required to assess for adverse events in this study. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins School of Medicine | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tolerability of skin-RF interactions in axillary skin | Tolerability will be assessed by number of patients experiencing adverse events grade 2 or higher as defined by the Common Terminology Criteria for Adverse Events. | 4 months | |
Primary | Safety of skin-RF interactions in axillary skin | Safety will be assessed by number of patients experiencing adverse events grade 2 or higher as defined by the Common Terminology Criteria for Adverse Events. | 4 months |
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